Specialist, Drug Safety
Core
Manage pharmacovigilance intake, prepare and submit Individual Case Safety Reports (ICSRs) and aggregate safety reports, and support audits/inspections to ensure regulatory compliance and patient safety across the Middle East.
Role type
Specialist, Pharmacovigilance (PV) / Drug Safety
Builds
Safety reports and compliance documentation for multiple markets in the Middle East
Domain
Healthcare / Pharmacovigilance / Regulatory Compliance
Deliverable
client delivery
Required skills
ICSR preparation, regulatory compliance, audit support, safety report aggregation, documentation management, local PV training delivery
Preferred skills
PV experience in other Middle Eastern countries
Technologies
None stated
Responsibilities
Manage PV intake and reconciliation, prepare and submit ICSRs and aggregate reports, support audits and inspections, deliver local PV training, escalate safety issues, serve as Deputy QPPV for Egypt
Seniority
Specialist, individual contributor
